If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Mucosolvan Side Effects Reported to FDA

This is a report of a 48-year-old male patient (weight: NA) from CN, suffering from the following health symptoms/conditions: increased upper airway secretion, who was treated with Mucosolvan (dosage: 20 Ml, start time:

Nov 24, 2013), combined with:

Amoxicillin

and developed a serious reaction and side effect(s): Heart Rate Increased, Chest Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mucosolvan treatment in male patients, resulting in Heart Rate Increased side effect.

This report suggests a potential MucosolvanRespiratory Failure side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Mucosolvan (dosage: NA) starting

This Left Ventricular Hypertrophy problem was reported by a physician from Germany. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On

May 19, 2011 this consumer started treatment with Mucosolvan (dosage: 75 Mg, Unk). The following drugs were being taken at the same time:

Norvasc (10 Mg, Unk)

Tacrolimus (10 Mg, Qd)

Prednisolone (5 Mg, Qd)

Metoprolol (300 Mg, Unk)

Aspirin (100 Mg, Unk)

Albuterol Sulfate (Unk)

Alvocidib (Unk)

Aspisol (500 Mg, Unk)

When using Mucosolvan, the patient experienced the following unwanted symptoms/side effects: Left Ventricular Hypertrophy, Heart Valve Incompetence, Arterial Stenosis, Vocal Cord Paralysis, Acute Myocardial Infarction, Chest Pain, Pneumonia, Urinary Tract Infection, EndocarditisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Left Ventricular Hypertrophy, may become evident only after a product is in use by the general population.

This Haemorrhagic Diathesis side effect was reported by a physician from Japan. A 89-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mucosolvan (ambroxol Hydrochloride) (drug dosage: NA), which was initiated on

This is a report of a female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: bronchitis, who was treated with Mucosolvan (dosage: 45mg Per Day, start time:

May 14, 2012), combined with:

Clarithromycin (400mg Per Day)

Acetaminophen (1500mg Per Day)

Relenza (4iuax Per Day)

and developed a serious reaction and side effect(s): Abnormal Behaviour, Delirium after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mucosolvan treatment in female patients, resulting in Abnormal Behaviour side effect.

Mucosolvan Side Effect Report#8265894-0Product Quality Issue

This report suggests a potential MucosolvanProduct Quality Issue side effect(s) that can have serious consequences. A 1-year-old male patient (weight: NA) from Kenya was diagnosed with the following symptoms/conditions: upper respiratory tract infection,pyrexia and used Mucosolvan (dosage: 15ml Per Day) starting

Jan 14, 2012. After starting Mucosolvan the patient began experiencing various side effects, including: Product Quality IssueAdditional drugs used concurrently:

Acetaminophen (10ml Per Day)

Cefuroxime (125mg Per Day)

Although Mucosolvan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Quality Issue, may still occur.

This Ventricular Fibrillation problem was reported by a physician from Japan. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On

Jan 05, 2012 this consumer started treatment with Mucosolvan (dosage: 45 Mg, 1x/day). The following drugs were being taken at the same time:

Zithromax (500 Mg, 1x/day)

Asverin (60 Mg, 1x/day)

Bakumondouto (27 G, 1x/day)

Zithromax

Depas (0.5 Mg, 1x/day)

When using Mucosolvan, the patient experienced the following unwanted symptoms/side effects: Ventricular Fibrillation, Electrocardiogram Qt Prolonged, Ventricular Tachycardia, Cardio-respiratory ArrestThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ventricular Fibrillation, may become evident only after a product is in use by the general population.

This Wheezing side effect was reported by a physician from Japan. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mucosolvan (drug dosage: Unk), which was initiated on

Dec 15, 2002. Concurrently used drugs:

Depas (Unk)

Theophylline (Unk)

Risedronate Sodium (Unk)

Omeprazole (Unk)

Spelear (Unk)

Aspara-ca (Unk)

Symbicort (Unk)

Montelukast Sodium (Unk)

.After starting to take Mucosolvan the consumer reported adverse symptoms, such as: Wheezing, Pyrexia, Platelet Count DecreasedThese side effects may potentially be related to Mucosolvan. The patient was hospitalized.

Mucosolvan Side Effect Report#8227793-XAortic Dissection, Arrhythmia

This is a report of a 78-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Mucosolvan (dosage: NA, start time:

Nov 15, 2011), combined with:

Budesonide W/formoterol Fumarate

Alfarol

Rabeprazole Sodium

and developed a serious reaction and side effect(s): Aortic Dissection, Arrhythmia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mucosolvan treatment in female patients, resulting in Aortic Dissection side effect. The patient was hospitalized.

Mucosolvan Side Effect Report#8192977-6Loss Of Consciousness

This report suggests a potential MucosolvanLoss Of Consciousness side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Mucosolvan (dosage: Unk) starting

Jan 01, 1985. After starting Mucosolvan the patient began experiencing various side effects, including: Loss Of ConsciousnessAdditional drugs used concurrently:

Marzulene Es /00518301/ (Unk)

Epinastine Hydrochloride (Unk)

Losartan Potassium (Unk)

Marzulene Es

Theo-dur (Unk)

Losartan Potassium (Unk)

Prednisolone (Unk)

Epinastine Hydrochloride (Unk)

Although Mucosolvan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Loss Of Consciousness, may still occur.

This Pyrexia problem was reported by a physician from Japan. A 20-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Mucosolvan (dosage: NA). The following drugs were being taken at the same time:

Zonisamide

Zonisamide

Epirenat

Keppra

Bisolvon

Baclofen

When using Mucosolvan, the patient experienced the following unwanted symptoms/side effects: Pyrexia, Musculoskeletal StiffnessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pyrexia, may become evident only after a product is in use by the general population.

This Chronic Obstructive Pulmonary Disease side effect was reported by a physician from Japan. A male patient (weight:NA) experienced the following symptoms/conditions: emphysema.The patient was prescribed Mucosolvan (drug dosage: 45 Mg), which was initiated on

Nov 20, 2010. Concurrently used drugs:

Spiriva (5 Mcg)

Bisolvon (12 Mg)

Levothyroxine Sodium (50 Mcg)

Garenoxacin Mesylate (200 Mg)

.After starting to take Mucosolvan the consumer reported adverse symptoms, such as: Chronic Obstructive Pulmonary Disease, PneumoniaThese side effects may potentially be related to Mucosolvan. The patient was hospitalized.

This is a report of a 81-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: emphysema, who was treated with Mucosolvan (dosage: NA, start time:

Oct 15, 2010), combined with:

Methy F

Diazoxide

Lansoprazole

Tamsulosin Hydrochloride

Pioglitazone Hydrochloride

Amaryl

Nipolazin

Ferrous Citrate

and developed a serious reaction and side effect(s): Hypoglycaemic Unconsciousness, Hypoxic-ischaemic Encephalopathy, Cardio-respiratory Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mucosolvan treatment in male patients, resulting in Hypoglycaemic Unconsciousness side effect. The patient was hospitalized.

This report suggests a potential MucosolvanDecreased Appetite side effect(s) that can have serious consequences. A 79-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: bronchitis chronic,gastrooesophageal reflux disease,hypertension,lumbar spinal stenosis and used Mucosolvan (dosage: 15 Mg, 3x/day) starting

This Pneumocystis Jiroveci Pneumonia problem was reported by a physician from Japan. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On

Apr 23, 2005 this consumer started treatment with Mucosolvan (dosage: Unk). The following drugs were being taken at the same time:

Amaryl (Unk)

Lafutidine (Unk)

Enbrel (25 Mg, 2x/week)

Methycobal (Unk)

Enbrel (25 Mg, Weekly)

Rimatil (200 Mg, 1x/day)

Aspirin (Unk)

Rinderon /00008501/ (1.5 Mg, 1x/day)

When using Mucosolvan, the patient experienced the following unwanted symptoms/side effects: Pneumocystis Jiroveci PneumoniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumocystis Jiroveci Pneumonia, may become evident only after a product is in use by the general population.

Mucosolvan Side Effect Report#7716875-4

This Sudden Death side effect was reported by a physician from Germany. A 91-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mucosolvan (drug dosage: NA), which was initiated on

Aug 24, 2011. Concurrently used drugs:

Ceftriaxon (1 Df, Unk)

Ramipril

Tramal Long

Enoxaparin Sodium

Avelox (Unk)

Torsemide

.After starting to take Mucosolvan the consumer reported adverse symptoms, such as: These side effects may potentially be related to Mucosolvan.

This is a report of a 81-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: emphysema, who was treated with Mucosolvan (dosage: NA, start time:

Jul 23, 2008), combined with:

Ferrous Citrate

Glycoran

Pioglitazone Hydrochloride

Lansoprazole

Tamsulosin Hydrochloride

Nipolazin

Amaryl

Methy F

and developed a serious reaction and side effect(s): Hypoglycaemic Unconsciousness, Cardio-respiratory Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mucosolvan treatment in male patients, resulting in Hypoglycaemic Unconsciousness side effect. The patient was hospitalized.

Mucosolvan Side Effect Report#7674902-7Hyponatraemia

This report suggests a potential MucosolvanHyponatraemia side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Mucosolvan (dosage: Unk) starting NS. After starting Mucosolvan the patient began experiencing various side effects, including: HyponatraemiaAdditional drugs used concurrently:

Sennoside (Unk)

Epinastine Hydrochloride (Unk)

Coniel (Unk)

Halomonth

Depas (Unk)

Cerekinon (Unk)

Zyprexa (15 Mg, Qd)

The patient was hospitalized. Although Mucosolvan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyponatraemia, may still occur.

This Anaphylactic Reaction problem was reported by a physician from China. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: postoperative care. On

May 18, 2011 this consumer started treatment with Mucosolvan (dosage: 15 Mg). The following drugs were being taken at the same time:

Atrovent (500 Mcg)

When using Mucosolvan, the patient experienced the following unwanted symptoms/side effects: Anaphylactic Reaction, AsphyxiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaphylactic Reaction, may become evident only after a product is in use by the general population.

Mucosolvan Side Effect Report#7630434-3Interstitial Lung Disease

This Interstitial Lung Disease side effect was reported by a physician from Japan. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mucosolvan (drug dosage: NA), which was initiated on

Jun 11, 2011. Concurrently used drugs:

Mucosta

Pursennid

Ulcerlmin

Amlodipine

Maalox

Paxil (20mg Per Day)

Clarithromycin

Zyloric 100 (100mg Per Day)

.After starting to take Mucosolvan the consumer reported adverse symptoms, such as: Interstitial Lung DiseaseThese side effects may potentially be related to Mucosolvan. The patient was hospitalized.

This is a report of a 68-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: bronchitis,nicotine dependence, who was treated with Mucosolvan (dosage: 45mg Per Day, start time:

Jun 06, 2011), combined with:

Varenicline Tartrate (0.5 Mg, 2x/day)

Varenicline Tartrate (0.5 Mg, 1x/day)

Varenicline Tartrate (1.0 Mg, 2x/day)

Sekinarin (2mg, Unk)

and developed a serious reaction and side effect(s): Apathy, Disturbance In Attention, Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mucosolvan treatment in female patients, resulting in Apathy side effect.

Mucosolvan Side Effect Report#7599679-5Hyponatraemia

This report suggests a potential MucosolvanHyponatraemia side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Mucosolvan (dosage: Unk) starting NS. After starting Mucosolvan the patient began experiencing various side effects, including: HyponatraemiaAdditional drugs used concurrently:

Coniel (Unk)

Alesion (Unk)

Depas (Unk)

Sennoside (Unk)

Cerekinon (Unk)

Zyprexa (15 Mg, Qd)

The patient was hospitalized. Although Mucosolvan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyponatraemia, may still occur.

This Anaphylactic Reaction problem was reported by a physician from China. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: postoperative care. On

May 18, 2011 this consumer started treatment with Mucosolvan (dosage: 15 Mg). The following drugs were being taken at the same time:

Atrovent (500 Mcg)

When using Mucosolvan, the patient experienced the following unwanted symptoms/side effects: Anaphylactic Reaction, AsphyxiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaphylactic Reaction, may become evident only after a product is in use by the general population.

This Hepatic Function Abnormal side effect was reported by a physician from Japan. A 80-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mucosolvan (drug dosage: Daily Dose 45 Mg), which was initiated on

This is a report of a 62-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Mucosolvan (dosage: NA, start time:

May 30, 2011), combined with:

Tegretol

Bisolvon (Unk)

and developed a serious reaction and side effect(s): Epilepsy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mucosolvan treatment in female patients, resulting in Epilepsy side effect.

The appearance of Mucosolvan on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

You can use them to remind you of details that may alert your health care professional(s) to a problem

You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

Log Form

You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

Medicine Name and Dosage:

Side Effects

Scale

Date & Time

Other Medicine(s) or Treatment(s)

Scale: 1 = very mild to 10 = very bad

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Mucosolvan reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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